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Participate In Initial Industry-FDA Meetings

Tips for Success

  • Discuss with the Sponsor how you can contribute during the meeting.
  • Be prepared to present analyzed patient data from patient registries, natural history studies, and patient preference studies, and discuss how this data informed or supports required elements of the IND application.
    • Making Data Talk: A Workbook by the National Cancer Institute (2011) is a workbook describing how to communicate public health data to the public, policy makers, and the press. Although written for a researcher/scientist familiar with statistical analysis, the definitions and tips within the workbook can help you understand the analysis of your own data and learn about the best way to communicate the information to others. 
  • Contact the FDA Patient Affairs , available at +1-301-796-8460, to understand the type of information or specific presentation formats that may be most helpful from the FDA’s perspective.
  • Reach out to other group leaders who have recently been involved in pre-IND meetings for investigational therapies being developed for their disease.
  • During the meeting, listen for ways you can help the Sponsor overcome any uncovered obstacles or missing information that may delay the submission of the IND application.
  • Schedule a follow-up meeting with the Sponsor to debrief the information learned in the meeting and to discuss next steps to move forward. 

Resources

Overview
How to Study and Market Your Device U. S. Food and Drug Administration (FDA) (link)
The Device Development Process U. S. Food and Drug Administration (FDA) (link)
Learn about Pre-IND Meetings
Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review U. S. Food and Drug Administration (FDA) (link)
Developing Products for Rare Diseases & Conditions U. S. Food and Drug Administration (FDA) (link)
Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting U. S. Food and Drug Administration (FDA) (link)
Prepare for the Meeting
Working with Regulators: A Focus on the FDA Cancer Policy Institute at the Cancer Support Community (link)
FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)
Biologics License Applications (BLA) Process (CBER) U. S. Food and Drug Administration (FDA) (link)
Target Product Profile Template Health and Human Services (HHS) ASPR (link)
The Target Product Profile Webinar Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) (link)
Tips for Success
Making Data Talk: A Workbook by the National Cancer Institute National Cancer Institute (NCI) (link)
FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)